Mannitol Administration for Delerium Prevention

Active, not recruiting

• Conditions: Myocardial Infarction (MI); Delirium, Intensive Care Unit, Randomised Controlled Trial

• Registration Number: NCT06759259
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.

Detailed Description

The pathogenesis of delirium in patients with myocardial infarction has not been fully studied, as a result of which delirium is currently considered a polyetiological syndrome. The ideas about the pathogenesis of delirium are formulated in a number of concepts, among which the neuroinflammatory theory is the most promising for study. The development of a systemic inflammatory reaction of both infectious and aseptic nature can lead to a violation of the permeability of the blood-brain barrier, followed by subclinical cerebral edema and impaired neurotransmitter metabolism. A single study of the adjuvant use of mannitol for the prevention of delirium, conducted in 2020 (Hamiko M.) proved the effectiveness of mannitol in the prevention of delirium in patients who underwent surgical aortic valve replacement, and served as a theoretical and experimental prerequisite for this study.

The study is prospective, randomized, open-label, controlled. It is planned to include 40 patients with myocardial infarction aged 65 years or older on the first day of the disease ("pain-door" \< 24 hours) and signs of a systemic inflammatory response (CRP\> 25 mg / L) in the main and control groups in a 1: 1 ratio. All patients will receive standard treatment for myocardial infarction upon admission in accordance with current recommendations. Patients will be randomized using a random number generator, after which patients in the main group will receive adjuvant therapy with mannitol at a dose of 1000 mg / kg according to the following scheme: bolus 250 mg / kg + infusion 66.6 mg / kg / hour until a total dose of 1000 mg / kg is reached. Patients in the control group will receive standard treatment for myocardial infarction. It is planned to evaluate clinical, laboratory, functional data and take blood samples for the study of markers of systemic inflammation and brain damage and other biomarkers on days 1, 3 and 7. Evaluation of remote outcomes is planned on days 30 and 90.

Study Timeline

• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2024-12-28
• Study Start: 2024-12-29
• Study First Posted: 2025-01-06
• Primary Completion: 2025-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 65 and over
• Myocardial infarction in the first day of illness ("pain to door" time < 254 hours)
• Serum CRP > 25 mg/L

Exclusion Criteria

• A known pathological process in the brain, psychiatric disorders
• Impossibility of conducting an assessment CAM-ICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delirium	1-14 days	Development of delirium during hospitalization

Secondary Outcome Measures

Name	Time	Method
ICU-LOS	1-30 days	Lenght of stay in ICU
In-hospital mortality	1-30 days	Death during hospitalization from all causes
In-hospital LOS	1-30 lays	Lenght of stay in hospital
Re-hospitalization due to MACE	1-90 days	Re-hospitalization due to MACE

Trial Locations

Locations (1)

Cardiology Reserch Institute Tomsk National Research Centre; 🇷🇺 Tomsk, Tomskaya Oblast, Russian Federation